Career Opportunities

Regulatory Affairs Specialist

Posted on:
Organization: Gorbel, Inc.
Location: Fishers, NY
Description:

Summary of Position
Responsible for the development of regulatory strategies for the Gorbel Medical product portfolio. Responsible for the preparation of regulatory submissions required to market new or modified medical devices in the domestic and international clinical markets. Responsible for development, refinement and maintenance of procedures and systems designed to ensure the product development process addresses all regulatory requirements as well as the objectives of the business. Supervise the Quality Manager and project manage design and manufacturing engineers in preparation and submission of regulatory applications, providing support to new product development and maintaining compliance with US and appropriate international regulatory requirements.

Essential Duties and Responsibilities
· Understands and interprets U.S. and international medical device regulatory requirements, provides guidance on requirements to product development, production, service and installation teams.
· Develops strategies for submissions to FDA and other regulatory agencies. Provides regulatory risk assessments and options to product development teams and management.
· Manages regulatory compliance, evaluates regulatory issues and provides accurate and timely recommendations and alternatives, as needed, to management and functional business departments.
· Interact effectively with functional business departments in order to coordinate and facilitate documentation required for submissions and design files, ensuring that timelines are met and files are comprehensive.
· Develops and maintains regulatory procedures and policies to ensure ongoing compliance of existing and new products.
· Oversees the product development team activities relating to design and development processes to ensure regulatory compliance.
· Responsible for the day-to-day oversight and management of assigned projects. Serves as the primary regulatory resource for change to and prioritization of projects.
· Compile and maintain appropriate technical documents for regulatory submissions.
· Provide leadership and direction to assigned resources. Provide timely and appropriate performance feedback.
· Responsible for preparing FDA submissions necessary for new product approvals/clearances which may include Class I exempt Registration and Listing, Premarket notifications-510(k)s, Premarket Approval Applications (PMAs) and supplements, Investigational Device Exemptions (IDEs) submissions.
· Coordinates preparation of additional information and data requested by regulatory agencies and prepares appropriate responses to such requests.
· Independently reviews and approves relevant documents, including engineering changes, advertising and promotional materials and product development reports.
· Serves as primary Gorbel Medical interface with regulatory agencies. Other duties as assigned.
· Evaluate changes to regulatory documents, updates, FDA requests and formulates strategies to
maintain compliance.

Supervisory Responsibilities
Will supervise the Gorbel Medical Quality Manager

 

Requirements:

Qualifications Required for Position

Possess a minimum 6 years medical device regulatory affairs experience.
Experience in effective interaction with manufacturing, quality, clinical/medical and marketing departments.
FDA Class I and Class II regulatory experience, (21 CFR, Part 820).
· A working knowledge of FDA and regulations and how to interpret and monitor updates with
experience or knowledge in US Title 21 CFR, Part 820
· Thorough understanding of Class I Design Controls

Prior 510(k) experience.
Experience with international regulations, particularly ISO 13485.
Demonstrated experience in project management and FDA medical device documentation.
Demonstrated ability to work effectively in a highly charged, fluid environment.
Demonstrated ability to independently manage multiple projects.
Very detail-oriented, well-organized and driven to meet deadlines and program goals.
Strong verbal and written communication skills, including the ability to make effective and persuasive presentations.
Good computer skills with knowledge of Microsoft Office.
Some domestic and international travel required (10-15%)
Bachelor’s degree in related field or equivalent experience
Preferred Experience

Previous supervisory experience.
Demonstrated working knowledge of engineering principles.
· Compliance Project Leader from inception to launch of medical device.
· International product launch.

Work Environment
Gorbel Medical is a division of Gorbel, Inc. based in Victor, New York. We have entered the physical rehabilitation space with a Class I exempt device for the physical rehabilitation space. We are enthusiastic individuals with entrepreneurial spirits who are dedicated to improving people’s lives in a collaborative, fun fast paced environment.

Required experience:

Mecical device regulatory affairs: 6 years

Required education:

Bachelor's

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